This is an observational, prospective cohort study to describe the demographic, clinical, immunologic, and virologic characteristics of HIV-infected children at participating clinical sites in Latin American countries. Enrollment in this study will consist of approximately 500 HIV-infected children in two cohorts who acquired HIV infection through mother-to-child transmission (MTCT). The first group will be a static cohort consisting of HIV-infected children who were five years of age or younger when previously enrolled into the NISDI Pediatric Protocol. The second cohort will be a dynamic cohort of prospectively enrolled, HIV-infected children who are five years of age or younger. We will characterize complications from both the disease and its treatments. Subjects will be evaluated every six months for approximately five years and assessments of growth, morbidity, disease progression and mortality will be made.

Further study details as provided by National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) ):

Secondary Outcome Measures:

HIV RNA copies [ Time Frame: q 6 months ]

CD4 + T cell count [ Time Frame: q 6 months ]

Estimated Enrollment:

2500

Study Start Date:

July 26, 2002

Detailed Description:

This is an observational, prospective cohort study to describe the demographic, clinical, immunologic, and virologic characteristics of HIV-infected children at participating clinical sites in Latin American countries. Enrollment in this study will consist of approximately 500 HIV-infected children in two cohorts who acquired HIV infection through mother-to-child transmission (MTCT). The first group will be a static cohort consisting of HIV-infected children who were five years of age or younger when previously enrolled into the NISDI Pediatric Protocol. The second cohort will be a dynamic cohort of prospectively enrolled, HIV-infected children who are five years of age or younger. We will characterize complications from both the disease and its treatments. Subjects will be evaluated every six months for approximately five years and assessments of growth, morbidity, disease progression and mortality will be made.

Eligibility

Ages Eligible for Study:

up to 21 Years (Child, Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

INCLUSION CRITERIA:

Static Cohort:

Previous participation in a NISDI Protocol

Less then 6 years of age (before their 6th birthday) at the time of enrollment into the NISDI Pediatric Protocol

HIV-infected

HIV infection must be documented in the medical records by:

For children less than 18 months old when tested, two or more of the following (separate determinations on separate blood specimens):

Positive HIV culture

Positive HIV DNA PCR

Positive neutralizable p24 antigen

Quantitative HIV RNA greater than or equal to 10,000 copies/ml

For children greater than or equal to 18 months old when tested, two or more of the following (separate determinations on separate blood specimens):

Reactive test for HIV antibody in a sample obtained at greater than or equal to 15 months of age with confirmatory test by Western Blot or Immunofluorescence assay

Positive HIV culture

Positive HIV DNA PCR

Positive neutralizable p24 antigen

Quantitative HIV RNA greater than or equal to 1,000 copies/ml

Documentation of maternal HIV infection by country appropriate National Guidelines

Signed informed consent from parent or legal guardian. An informed assent document will be provided for children 8 years of age or older when appropriate.

Subjects must be able to be followed at a participating clinical site.

Subjects may be co-enrolled in clinical trials for treatment of HIV infection, opportunistic infections, or other HIV-related effects.

Dynamic cohort:

HIV-infected less then 6 years of age (before their 6th birthday) at enrollment into this protocol

HIV infection documented by:

For children <18 months old when tested, two or more of the following (separate determinations on separate blood specimens):

Positive HIV culture

Positive HIV DNA PCR

Positive neutralizable p24 antigen

Quantitative HIV RNA greater than or equal to 10,000 copies/ml

For children greater than or equal to 18 months old when tested, two or more of the following (separate determinations on separate blood specimens):

Reactive test for HIV antibody in a sample obtained at greater than or equal to 15 months of age with confirmatory test by Western Blot or Immunofluorescence assay

Positive HIV culture

Positive HIV DNA PCR

Positive neutralizable p24 antigen

Quantitative HIV RNA greater than or equal to 1,000 copies/ml

Documentation of maternal HIV infection by country appropriate National Guidelines

Signed informed consent from parent or legal guardian. An informed assent document will be provided for children 8 years of age or older when appropriate.

Subjects must be able to be followed at a participating clinical site

Subjects may be co enrolled in clinical trials for treatment of HIV infection, opportunistic infections, or other HIV related effects

EXCLUSION CRITERIA:

Children who are born to an HIV infected mother, but are uninfected or of indeterminate HIV infection status

Children who are orphans without legal guardians or are wards of the state

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00339612

Locations

Brazil

Universidade Federal de Minas Gerais

Belo Horizonte, Brazil

Ricardo de Souza STD/HIV Clinic-Caxias do Sul

Caxias do Sul, Brazil

Hospital Conceicao

Porto Alegre, Brazil

Hospital de Clinicas

Porto Alegre, Brazil

Hospital Femina

Porto Alegre, Brazil

Irmandade Da Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Brazil

Hospital dos Servidores do Estado

Rio de Janeiro, Brazil

Hospital Geral Nova de Iguacu

Rio de Janeiro, Brazil

Instituto de Puericultura e Pediatria Martagao Gesteira

Rio de Janeiro, Brazil

Instituto de Infectologica Emilio Ribas (IIER)

San Paulo, Brazil

Federal University of Sao Paulo-Escola Paulista de Medicina

Sao Paulo, Brazil

Hospital das Clinicas da Falculdade De Medinica

Sao Paulo, Brazil

Mexico

Hospital Infantil de Mexico Federico Gomez (HIM)

Mexico City, Mexico

Peru

University of San Marcos

Lima, Peru

Sponsors and Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Principal Investigator:

Rohan Hazra, M.D.

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)